Condition: ME/CFS · IBS - Irritable Bowel Syndrome · Sponsor: Nova Southeastern University
This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with irritable bowel syndrome (IBS). The main questions it aims to answer are: * how effective is the usage of the i3.1 probiotic to reduce gastrointestinal (GI) inflammation and normalize the GI and systemic/brain interface? * how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV criteria). Participants will receive an i3.1 or a placebo and be assessed at baseline, at eight weeks, and at 12 weeks (four weeks post-treatment completion).
This description comes directly from the study's public registry record.
Nancy Klimas, MD · 9542622855 · nklimas@nova.edu
Devra Cohen, MPH · 9542621487 · dcohen1@nova.edu
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| Institute for Neuroimmune Medicine | Fort Lauderdale, Florida, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06211062